Z-0406-2014Class II

Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm

Name: Z-0406-2014 Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm
Creator: Synthes (USA) Products LLC
Published: 2013-07-30
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2013-07-30 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and... on 2013-07-30. FDA classified it as Class II and gives the reason as "A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0406-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-11-27
Terminated: 2015-08-17
Recalling firm: Synthes (USA) Products LLC
Product: Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
Product code: HRS Plate, Fixation, Bone
Reason for recall: A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
Quantity in commerce: 13
Distribution: Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.
Product codes and lots: Part No. 249.926, lot No. 8093100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0406-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0406-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code HRS

K001941Class IISynthes Modular Foot SystemSynthes (Usa) / cleared 2000-09-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)